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Study of Bloat Gummies for Post-Meal Bloating

This study is looking at how well "Bloat Gummies" work to reduce bloating, gas, and stomach discomfort after eating. We are looking for healthy adults, aged 18-65, who experience frequent bloating after meals. You should have a Body Mass Index (BMI) under 29.9 kg/m² and your bloating should not be due to a diagnosed stomach or gut condition. Participants will take either Bloat Gummies or a placebo (an inactive substance that looks like the real thing) after two standardized meals. The main goal is to see if Bloat Gummies can reduce bloating severity within 60 minutes after taking them, compared to the placebo. The study plans to enroll 100 people.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 100 participants to compare Bloat Gummies with a placebo.
What's involved
You will take two gummies (either Bloat Gummies or placebo) 30 minutes after eating a standardized meal during two separate test sessions, at least 7 days apart. You will also answer questionnaires about gas, bloating, and abdominal discomfort.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured up to 60 minutes after taking the dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07516587

Study to Investigate the Efficacy of a Digestive Health Dietary Supplement on Post-meal Bloating in Healthy Participants

Not Yet Recruiting
NAAges 18–65Interventional
Arrae
~100 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:Bloat GummiesPlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean change in bloating severity from pre-dose to t = 60 minutes post-dose as, comparing active product vs. placebo.
Measured over Evaluated from pre-dose to 60 minutes post-dose

Conditions

Digestive Health
Abdominal Discomfort
Gas and Bloating

Explore related trials

Abdominal Distension

NCT07516587

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Alethios, Inc.

    San Francisco, Californiastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Alethios
[email protected]
650-206-8006
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Healthy male and female individuals aged 18-65 years at time of screening.
Body mass index (BMI) \<29.9 kg/m².
Self-reported recurrent postprandial abdominal bloating and/or distension occurring on average at least 2 days per week over the past 3 months, predominating over other gastrointestinal (GI) symptoms, and in the absence of a diagnosed gastrointestinal disease.
Females of child-bearing potential must have a negative baseline pregnancy test and agree to use a medically approved method of birth control for the duration of the study.
Willing to consume a standardized test meal consisting of 2 slices of large cheese pizza from Dominos on each test day.
Willing to complete online surveys and at-home measurements (waist circumference) at scheduled time points.
Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study.
Provides voluntary, written, informed consent to participate in the study prior to any study procedures.
Has reliable access to internet and a smartphone or computer capable of completing electronic surveys and attending virtual check-ins.

Exclusion

Current or past diagnosis of any significant disease of the GI tract, including but not limited to: irritable bowel syndrome (IBS), celiac disease, inflammatory bowel disease (Crohn's disease or ulcerative colitis), functional constipation, gastroesophageal reflux disease (GERD), gastroparesis, or treatment for H. pylori infection or gastric ulcer within the past year.
Significant or untreated medical and/or psychiatric disorders, including but not limited to: severe unstable diabetes, recent myocardial ischemia or infarction, unstable angina, cancer (except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative or volunteers with cancer in full remission for more than five years after diagnosis are acceptable), uncontrolled hypertension, renal failure, chronic active hepatitis, acute hepatitis, cirrhosis, Acquired Immunodeficiency Syndrome (AIDS), malignancy, and neurological disorders including epilepsy, recent cerebrovascular disease, or recent traumatic brain injury.
Current use of digestive enzyme supplements, prebiotics/fibers, probiotics, postbiotics, bloating-targeted supplements, therapeutic iron supplementation (\>65 mg elemental iron per dose), prokinetic agents, antacids, H2 blockers, proton pump inhibitors (PPIs), opioids, or loperamide within 14 days prior to the first test meal session; or use of any of the above during the study period.
Esophageal obstruction or difficulty swallowing.
Wear dentures.
Pregnant, breastfeeding, or planning to become pregnant during the study.
Known allergy, or sensitivity to any ingredient of the study supplement or placebo, including ginger, lemon balm, dandelion, or Bifidobacterium longum-derived products.
Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of standardized meal ingredients.
Alcohol use disorder or drug abuse/dependence within the past 6 months (\>2 standard drinks/day on average).
Currently following an extremely restrictive diet or having done so within the past 3 months.
Participation in another clinical research trial within 30 days prior to randomization.
Cognitively impaired or unable to provide informed consent.
Any other condition that, in the Investigator's opinion, may adversely affect the participant's ability to complete the study or its measures, or that may pose significant risk to the participant.

What this trial measures

  • Mean change in bloating severity from pre-dose to t = 60 minutes post-dose as, comparing active product vs. placebo.Evaluated from pre-dose to 60 minutes post-dose

    Bloating severity assessed by Bloating Likert Scale of 0 to 4, with 0 being "no symptoms" and 4 being "severe symptoms."